FDA Grants bioMérieux Special 510(k) Clearance and CLIA-waiver for New BIOFIRE SPOTFIRE Panel

bioMérieux’s BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. FDA Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments).

 

BIOFIRE SPOTFIRE R/ST Panel Mini is a unique multiplex PCR test that detects 5 of the most common viral and bacterial causes of respiratory or sore throat infections¹ in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected.

 

The BIOFIRE SPOTFIRE range matches new medical needs in the medical market brought out by the COVID-19 pandemic. The new range is a fast and innovative syndromic testing solution that allows healthcare professionals to have diagnostic tests as close as possible to the patient and provide actionable results quickly.

 

“The medical community continues to bring enhanced technology closer to patients, allowing clinicians to have more information to make real-time decisions. Regarding strep throat, Group A Streptococcus accounts for approximately 20% of sore throat cases and has historically been diagnosed via antigen tests. Including it on this PCR panel with common viral causes of strep throat, including rhinovirus, represents a step forward in healthcare, ultimately increasing diagnostic yield and removing the need to reflex to culture in most patients,” said Dr Charles K. Cooper, Executive Vice-President, Chief Medical Officer.  

 

The BIOFIRE SPOTFIRE system is a unique POC platform providing fast results and offering flexibility with the capability of running either a large multiplex respiratory test with up to 15 pathogens with the BIOFIRE SPOTFIRE R/ST Panel, or a small multiplex respiratory test with 5 pathogens with the BIOFIRE SPOTFIRE R/ST Panel Mini. This flexibility allows clinicians to choose the right test for their patients.

 

Jennifer Zinn, Executive Vice President of Clinical Operations, commented, “With our BIOFIRE SPOTFIRE R/ST Panel Mini, we bring a fast, highly sensitive and targeted panel to test for 4 of the most common respiratory viruses (including influenzas) and Streptococcus A, from one throat swab, all at the same time. Our offer meets the current needs of the growing decentralized, POC market bringing syndromic testing to the frontline of patient care. With this innovation, clinicians now can confidently tell their patients quickly what is making them sick and get them on the right treatment pathway, limiting the overuse of antibiotics.”

 

This is the fourth panel in the BIOFIRE SPOTFIRE range to be FDA-cleared and CLIA-waived. BIOFIRE SPOTFIRE R/ST Panel Mini will be available in the third quarter of 2024 in the United States. It is intended to be commercialized together with the larger multiplex BIOFIRE SPOTFIRE R/ST Panel to further expand bioMérieux’s presence in the North American outpatient market.